Orthopedic › ProstheticIntervertebral Fusion Device With Bone Graft, Lumbar

EndoLIF®

Working Tube EndoLIF® L 161 mm / OD 16 mm / ID 15 mm

Registry build 21.09.26
14manufacturers in China registered for this device type
75catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MAX
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar

Record

Regulatory record for EndoLIF®
Listed by Joimax Gmbh, Germany
FDA product code MAX
Device type Intervertebral Fusion Device With Bone Graft, Lumbar
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
510(k) K151143
Record published 2015-09-24
Record revised 2022-09-16 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for EndoLIF®
Catalogue number Size Status
ELON643012 In distribution
ELDL6425108 L 25 mm / H 10 mm / AG 8° / W 10 mm In distribution
ELDW64271112 L 27 mm / H 11 mm / AG 12° / W 12 mm In distribution
ELO643013 L 30 mm / W 12 mm / H 13 mm In distribution
ELON643508 In distribution
ELON643011 In distribution
ELON643512 In distribution
ELDW64321312 L 32 mm / H 13 mm / AG 12° / W 12 mm In distribution
ELDW64271418 L 27 mm / H 14 mm / AG 18° / W 12 mm In distribution
ELDL6425104 L 25 mm / H 10 mm / AG 4° / W 10 mm In distribution
ELDW64271312 L 27 mm / H 13 mm / AG 12° / W 12 mm In distribution
ELDW64271018 L 27 mm / H 10 mm / AG 18° / W 12 mm In distribution
EIT502550 In distribution
ELDW64321118 L 32 mm / H 11 mm / AG 18° / W 12 mm In distribution
ELO643008 L 30 mm / W 12 mm / H 8 mm In distribution
ELO643510 L 35 mm / W 12 mm / H 10 mm In distribution
ELON643513 In distribution
ELON643509 In distribution
ELON643008 In distribution
ELON643013 In distribution
ELDW64271512 L 27 mm / H 15 mm / AG 12° / W 12 mm In distribution
ELDW64271612 L 27 mm / H 16 mm / AG 12° / W 12 mm In distribution
ELO643514 L 35 mm / W 12 mm / H 14 mm In distribution
ELDL6425114 L 25 mm / H 11 mm / AG 4° / W 10 mm In distribution
ELDW64321012 L 32 mm / H 10 mm / AG 12° / W 12 mm In distribution
ELDW64321112 L 32 mm / H 11 mm / AG 12° / W 12 mm In distribution
ELDL6425084 L 25 mm / H 08 mm / AG 4° / W 10 mm In distribution
ELDL6425088 L 25 mm / H 08 mm / AG 8° / W 10 mm In distribution
ELDW64271618 L 27 mm / H 16 mm / AG 18° / W 12 mm In distribution
ELDW64271212 L 27 mm / H 12 mm / AG 12° / W 12 mm In distribution
ELDW64321618 L 32 mm / H 16 mm / AG 18° / W 12 mm In distribution
DTEQ181215 In distribution
ELDW64271412 L 27 mm / H 14 mm / AG 12° / W 12 mm In distribution
ELON643514 In distribution
ELON643010 In distribution
ELDL6425124 L 25 mm / H 12 mm / AG 4° / W 10 mm In distribution
ELDW64271218 L 27 mm / H 12 mm / AG 18° / W 12 mm In distribution
ELDW64321318 L 32 mm / H 13 mm / AG 18° / W 12 mm In distribution
ELDL6425094 L 25 mm / H 09 mm / AG 4° / W 10 mm In distribution
WTE151615 In distribution
ELO643513 L 35 mm / W 12 mm / H 13 mm In distribution
ELO643010 L 30 mm / W 12 mm / H 10 mm In distribution
ELON643014 In distribution
WTEQ161013 In distribution
ELDW64321512 L 32 mm / H 15 mm / AG 12° / W 12 mm In distribution
ELO643509 L 35 mm / W 12 mm / H 9 mm In distribution
ELDW64271118 L 27 mm / H 11 mm / AG 18° / W 12 mm In distribution
ELDW64321412 L 32 mm / H 14 mm / AG 12° / W 12 mm In distribution
ELDW64271318 L 27 mm / H 13 mm / AG 18° / W 12 mm In distribution
ELDW64321212 L 32 mm / H 12 mm / AG 12° / W 12 mm In distribution
WTE171918 In distribution
ELO643512 L 35 mm / W 12 mm / H 12 mm In distribution
ELDL6425128 L 25 mm / H 12 mm / AG 8° / W 10 mm In distribution
WTEQ161513 In distribution
EIT502550C In distribution
DTEQ199013 In distribution
DTEQ199010 In distribution
ELO643508 L 35 mm / W 12 mm / H 8 mm In distribution
ELON643009 In distribution
ELDW64321418 L 32 mm / H 14 mm / AG 18° / W 12 mm In distribution
WTEQ161313 In distribution
ELDL6425118 L 25 mm / H 11 mm / AG 8° / W 10 mm In distribution
ELO643014 L 30 mm / W 12 mm / H 14 mm In distribution
ELDW64271518 L 27 mm / H 15 mm / AG 18° / W 12 mm In distribution
ELDW64321218 L 32 mm / H 12 mm / AG 18° / W 12 mm In distribution
ELON643510 In distribution
ELO643011 L 30 mm / W 12 mm / H 11 mm In distribution
ELO643511 L 35 mm / W 12 mm / H 11 mm In distribution
ELDW64321612 L 32 mm / H 16 mm / AG 12° / W 12 mm In distribution
ELDL6425098 L 25 mm / H 09 mm / AG 8° / W 10 mm In distribution
ELDW64321518 L 32 mm / H 15 mm / AG 18° / W 12 mm In distribution
ELDW64271012 L 27 mm / H 10 mm / AG 12° / W 12 mm In distribution
ELO643012 L 30 mm / W 12 mm / H 12 mm In distribution
ELON643511 In distribution
ELDW64321018 L 32 mm / H 10 mm / AG 18° / W 12 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Peridot Intervertebral body fusion system Gbs Commonwealth Co., Ltd. 10,850
Yellowstone Summit Spine 6,654
CoRoent Nuvasive, Inc. 5,690
Zavation Zavation 2,554
Anyplus II Spinal Fixation System GS Medical Co., Ltd. 2,533
Talos® IBF Meditech Spine, LLC 2,163
Peridot-PT Intervertebral body fusion system Gbs Commonwealth Co., Ltd. 1,956
TirboLOX-L Lumbar Ibfd Captiva Spine, Inc. 1,926
Endoskeleton® TL Titan Spine, LLC 1,896
Evos Lumbar Interbody System Cutting Edge Spine 1,871
Epiphany Pantheon Spinal LLC 1,507
LnK Lumbar Interbody Fusion Cage System L&K Biomed Co., Ltd. 1,506

Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K203014 2021-09-01
K151143 2015-07-09

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number Decision Trade name Approved to
P000028 2004-06-18 AFFINITY ANTERIOR CERVICAL CAGE SYSTEM Medtronic Sofamor Danek USA, Inc.
P970015 2003-09-10 LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE Sofamor Danek
P980048 2001-04-20 BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM Sulzer Spine-Tech
P950019 1999-03-19 RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION Stryker Spine
P950002 1997-06-30 BAK INTERBODY FUSION SYSTEM Zimmer Spine, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer